Trial results for the PREMIER study investigating obesity and metabolic health were posted on ClinicalTrials.gov on 2025-06-08, indicating that a genotype-of-interest group generally exhibited lower glucose levels compared to a control group.
Background
Obesity and type 2 diabetes epidemics are significantly influenced by dietary intake. While adherence to healthy dietary recommendations can reduce the incidence of these conditions, individual responses to dietary interventions vary widely. Understanding the biological, environmental, and social factors that influence how individuals interact with diet is crucial for developing more effective prevention strategies. This study aimed to explore aspects of precision nutrition to inform such strategies.
Trial design
This completed study, designated as Phase NA, enrolled 22 participants. The trial investigated conditions including Obesity, Type 2 Diabetes, Metabolic Syndrome, Diet Habit, and Nutritional and Metabolic Disease. The study compared a "Genotype of Interest Group" with a "Control" group, focusing on understanding individual responses to dietary interventions, consistent with its brief title, PREMIER: PREvention of Metabolic Illness Through prEcision nutRition.
Key results
The trial reported several key measurements:
- Glucose at Times 30min, 60min, 120min, 180min (units: mg/dL):
- At 30 minutes, the Genotype of Interest Group had a mean glucose of 112.9 (Standard Deviation 19.3), while the Control group had a mean of 119.8 (Standard Deviation 15.6).
- At 60 minutes, the Genotype of Interest Group had a mean glucose of 94.5 (Standard Deviation 24.1), while the Control group had a mean of 118.4 (Standard Deviation 34.3).
- At 120 minutes, the Genotype of Interest Group had a mean glucose of 84.1 (Standard Deviation 22.5), while the Control group had a mean of 94.1 (Standard Deviation 10.9).
- At 180 minutes, the Genotype of Interest Group had a mean glucose of 80.8 (Standard Deviation 12.5), while the Control group had a mean of 81.9 (Standard Deviation 9.4).
- High-fat Meal Preference (units: Participants):
- 8 participants in the Genotype of Interest Group were noted for high-fat meal preference.
- 3 participants in the Control group were noted for high-fat meal preference.
- Metabolomics by Mass Spectrometry Analysis (Reported as Fold Change in Metabolites From Baseline) (units: fold-change from baseline):
- The Genotype of Interest Group had a mean fold change of 10.4 (Standard Deviation 8.8).
- The Control group had a mean fold change of 4.2 (Standard Deviation 4.0).
What this means
The results from the PREMIER study suggest potential differences in metabolic responses between the genotype-of-interest group and the control group, particularly regarding post-meal glucose levels. The genotype-of-interest group consistently showed lower mean glucose values across multiple time points after a meal. Additionally, this group exhibited a higher mean fold change in metabolites from baseline as measured by mass spectrometry, and 8 participants in the genotype-of-interest group were noted for high-fat meal preference compared to 3 in the control group. These findings contribute to understanding inter-individual variability in response to dietary factors, which is a key aspect of precision nutrition research, though the small sample size of 22 participants warrants further investigation.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT04148482, titled "PREMIER: PREvention of Metabolic Illness Through prEcision nutRition", were posted on 2025-06-08 on clinicaltrials.gov.